1-617-500-6690 [email protected]
  • Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: Lead CRA

Job Number: 31999

Location: Remote, 

Job Description

This person will play a crucial role in being responsible for tasks that relate to the operations and management of clinical trials.  The Lead Clinical Research Associate may be located in-house in the HQ, a client’s office, or be regionally based.

Responsibilities

  •  Monitoring:
  • Acting as primary liaison between the study site staff and Sponsor Company
  • Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples
  • Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
  • Reviewing investigational product accountability, including discrepancy resolution
  • Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines
  • Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies
  • Visit report writing and site correspondence
  • Monitoring clinical studies of investigational and approved products.  This may include qualification, initiation, interim monitoring, and close out site visits
  • Monitoring studies by reviewing and reporting to the Sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalit
  • Communications/Management:
  • Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions
  • Supervision and guidance of CRAs, CTAs, and external CROs.  Conduct co-monitoring, training and audit visits.  Creation of visit report templates.  Review of completed visit reports
  • Visit report writing and site correspondence
  • Managing the resource requirements of the project
  • Interdepartmental liaison working with regulatory, data management, biostatistics and clinical groups to develop and maintain clinical plan
  • Document/Supply Tracking:
  • Managing the preparation, collection and maintenance of trial regulatory documents
  • Maintaining study files to ensure all appropriate documentation is present
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
  • Managing investigational product ordering, packaging, labeling and ongoing inventory
  • Document/Presentation Preparation:
  • Managing the reporting of serious adverse events
  • Developing study-related documents such as protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans
  • Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules
  • Planning, preparing for, and giving presentations at investigator meeting

Required Skills

  • RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience.

 

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